James Henry Provisions Company d/b/a James Henry & Company, DAB TB8839 (2024)

INITIAL DECISION

Found:

1. Respondent violated 21 U.S.C. § 301 et seq., specifically 21 U.S.C. § 331(c), as charged in the Complaint;
2. Respondent committed at least one violation as set forth hereinafter; and
3. Respondent is hereby assessed a reduced civil penalty in the amount of $10,500.

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Glossary:

I.      JURISDICTION

I have jurisdiction to hear this case pursuant to my appointment by the Secretary of Health and Human Services and my authority under the Administrative Procedure Act (5 U.S.C. §§ 554-556), 5 U.S.C.A. § 3106, 21 U.S.C. § 333(f)(5), 5 C.F.R. §§ 930.201 et seq. and 21 C.F.R. Part 17.²

II.     PROCEDURAL BACKGROUND

The Center for Tobacco Products (CTP/Complainant) filed a Complaint on January 29, 2024, against James Henry Provisions Company d/b/a James Henry & Company, (Respondent or James Henry & Company), located at 434 North 4th Street, Saint Louis, Missouri 63102.  Civil Remedies Division (CRD) Docket (Dkt.) Entry No. 1 (Complaint).  The Complaint alleges that Respondent received in interstate commerce an

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electronic nicotine delivery system (ENDS) product that lacks the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act and offered such product for sale.  Complaint at 1.

Respondent was served with process on January 23, 2024, by United Parcel Service.  CRD Dkt. Entry No. 1b (Proof of Service).  On February 19, 2024, Counsel for Respondent filed a Notice of Appearance and a request for an extension of time to file an answer.  CRD Dkt. Entry Nos. 4, 5.  On February 21, 2024, I issued an order granting Respondent’s request for an extension to file an answer.  CRD Dkt. Entry No. 7.  On March 25, 2024, Counsel for Respondent filed an Answer to the Complaint.  CRD Dkt. Entry No. 8 (Answer).  In its Answer, Respondent denied the cited allegations in the Complaint, offered some defenses, argued that the Warning Letter Respondent received addressed a different product than what Respondent was cited for in this Complaint, and asserted that Respondent cannot afford to pay the civil money penalty (CMP) CTP is seeking.  Answer at 2.

On March 27, 2024, I issued a Pre-Hearing Order (PHO) establishing what the parties must do to present evidence and arguments in this case.  CRD Dkt. Entry No. 9 (PHO).  The PHO directed the parties to file their pre-hearing exchanges by June 26, 2024.  PHO at 3.

On May 9, 2024, CTP filed a Motion for a Protective Order (MPO), requesting a protective order limiting CTP’s disclosure in response to Respondent’s Request for Production of Documents (RFP).  CRD Dkt. Entry No. 11.  On May 29, 2024, CTP filed

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an Unopposed Motion to Extend Deadlines requesting an extension of the pre-hearing exchange deadlines.  CRD Dkt. Entry No. 12.

On May 30, 2024, I issued an Order Granting Motion to Extend Deadlines, giving both parties until June 5, 2024 to file their respective pre-hearing exchanges.  CRD Dkt. Entry No. 13.  On May 31, 2024, CTP filed a Memorandum of Law in Support of Complainant’s Motion for a Protective Order and attached proposed exhibits in support of its motion.  CRD Dkt. Entry Nos. 14, 14a-14d.  In response, on June 17, 2024, Respondent filed Respondent’s Memorandum in Opposition to Complainant’s Motion for a Protective Order and one proposed exhibit.  CRD Dkt. Entry Nos. 15, 16.

On June 26, 2024, CTP filed its pre-hearing exchange consisting of an informal brief, a list of proposed witnesses, and seven proposed exhibits.  CRD Dkt. Entry Nos. 17, 17a-17h.  Specifically, the written direct testimony of two proposed witnesses: Deputy Division Director for the Division of  Enforcement and Manufacturing in the Office of Compliance and Enforcement, CTP, FDA, James Bowling, and FDA-commissioned Inspector Kevin Weaver.  CRD Dkt. Entry No. 1, 2, respectively.

On July 3, 2024, Counsel for Respondent submitted its pre-hearing exchange consisting of an informal brief, and pre-hearing disclosures including five proposed exhibits which included the declaration of one witness, Amit Patel, Respondent’s Owner and Operator.  CRD Dkt. Entry Nos. 18, 18a-18f.

On August 20, 2024, I issued an Order Granting in Part and Denying in Part

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Complainant’s Motion for a Protective Order, to include all documents responsive to Respondent’s discovery request that are not subject to the protective order, pursuant to 21 C.F.R. § 17.23(d)(4).  CRD Dkt. Entry No. 19.

On August 27, 2024, I issued an order scheduling a hearing for September 25, 2024.  CRD Dkt. Entry No. 20 (Order Scheduling Telephone Hearing).  The Order directed both parties to file any motions to exclude or objections to the other party’s proposed exhibits, by September 10, 2024.  Order Scheduling Telephone Hearing at 1.  The Order Scheduling Telephone Hearing also informed the parties that if neither party wished to cross-examine the other parties’ witnesses, I would cancel the September 25, 2024 hearing and issue a written decision on the record.  Id at 2.

On September 10, 2024, CTP filed a Notice of Intent to Waive Hearing, stating that it had no objections to Respondent’s proposed exhibits and did not intend to cross-examine Respondent’s witness, and requested that a decision on the written record be issued.  CRD Dkt. Entry No. 21.  On September 11, 2024, Respondent also filed a Notice of Intent to Waive Hearing, stating the same.  CRD Dkt. Entry No. 22.

On September 17, 2024, I issued an order cancelling the September 25, 2024 hearing.  CRD Dkt. Entry No. 23 (Order Canceling Hearing).  In the Order, I gave the parties 10 days from the date of the order to move, by written motion, to admit its proposed exhibits into evidence, noting that otherwise, the exhibits would be excluded as evidence, but will remain a part of the administrative record.  Id. at 2.

On September 27, 2024, CTP filed a Motion to Admit Evidence, requesting that its proposed exhibits be admitted into evidence.  CRD Dkt. Entry No. 24.  Also on

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September 27, 2024, Respondent’s Counsel filed a Motion to Admit Evidence and Respondent’s Amended Brief – Final along with five additional proposed exhibits.  See CRD Dkt. Entry Nos. 26, 25, 25a-g, respectively.  Respondent requested that its pre-hearing disclosures, Amended Brief - Final, and proposed additional exhibits be admitted into evidence in addition to the case being decided on the written record.  CRD Dkt. Entry No. 26.  Respondent did not request that its previously filed proposed exhibits be admitted into to evidence and thus they are excluded as evidence but remain part of the administrative record.  Id.  Respondent’s filing was silent regarding objections to CTP’s exhibits.  Id.

Therefore, I ADMIT both parties’ exhibits into evidence as requested and the administrative record is now closed and ready for a decision based on the written record.  21 C.F.R. § 17.45(c).

III.    BURDEN OF PROOF

As the petitioning party, CTP, has the burden to prove, by a preponderance of the evidence, that Respondent is liable and that the proffered penalty is appropriate.  21 C.F.R. § 17.33.

IV.    LAW

21 U.S.C. § 301 et seq., specifically 21 U.S.C. § 331(c), 21 U.S.C. § 387b(6)(A), 21 U.S.C. § 387c(a)(6), and 21 U.S.C. § 387j(a)(2)(A).

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V.     ISSUES

Did Respondent violate 21 U.S.C. § 301 et seq., specifically 21 U.S.C. § 331(c), as alleged in the Complaint and, if so, is the civil money penalty sought by CTP appropriate?

VI.    ALLEGATIONS

1. Complainant’s Recitation of the Facts

In its Complaint, CTP alleged that Respondent owns an establishment, doing business under the name James Henry & Company, located at 434 North 4th Street, Saint Louis, Missouri 63102.  Complaint ¶ 13.  CTP also alleged that Respondent’s establishment received tobacco products, including an Esco Bars Fuji Apple Ice ENDS product, in interstate commerce and delivered or proffered delivery of such tobacco products for pay or otherwise.  Id. ¶ 14.

CTP’s Complaint further alleged that on June 5, 2023, CTP issued a Warning Letter to Respondent, stating that the new tobacco products that Respondent sells and/or distributes are adulterated and misbranded because they lack the required FDA marketing authorization.  Id. ¶ 20.

During a subsequent inspection of James Henry & Company on August 14, 2023, an FDA‑commissioned inspector observed an Esco Bars Fuji Apple Ice ENDS product for sale at Respondent’s establishment.  Id. ¶ 15.

Respondent’s ENDS products are a “new tobacco product” because it was not commercially marketed in the United States as of February 15, 2007.  Id. ¶ 16.  Respondent’s ENDS product does not have an order permitting marketing of the new

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tobacco product under 21 U.S.C. § 387j(c)(1)(A)(i) and is therefore adulterated under 21 U.S.C. § 387b(6)(A).  Id. ¶ 17.

Respondent neither submitted a substantial equivalent report nor an abbreviated report for Respondent’s ENDS product, and the product is therefore, misbranded under 21 U.S.C. § 387c(a)(6).  Id. ¶ 18.

Respondent’s receipt of an adulterated and misbranded ENDS product in interstate commerce and delivery or proffer thereof for pay or otherwise violates of 21 U.S.C. § 331(c).  Id. ¶ 19.

2. Respondent’s Recitation of the Facts

In its Answer, Respondent does not deny that it owns the establishment that does business under the name James Henry & Company, located at 434 North 4th Street, Saint Louis, Missouri 63102, and subsequently admitted to such in its Amended Informal Brief.  Answer at 2; CRD. Dkt. Entry No. 25 at 3.

Respondent asserts a general denial of the current allegations cited in Complaint paragraphs 14-21, including that its business establishment received tobacco products in interstate commerce, specifically an Esco Bars Fuji Apple Ice ENDS product, and delivered or proffered delivery of such tobacco products for pay or otherwise.  Id.; see also Complaint ¶¶ 14-21.  Although Respondent admits to receiving a Warning Letter on June 5, 2023, Respondent contends that the Warning Letter was for a different product.  Answer at ¶ 2.

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Respondent further denies that its ENDS product is a “new tobacco product,” and that it had any knowledge that its e-liquid products are adulterated or misbranded.  CRD Dkt. Entry No. 25 at 3.

Upon weighing the evidence, I conclude the FDA never issued a marketing authorization for the new tobacco product Respondent had in its business establishment.  I also find that there is no dispute that those same products did not have a substantial equivalence order or an exemption order from the Secretary.  Further, I find that Respondent’s possession of the new tobacco product occurred by way of interstate commerce.  Therefore, the new tobacco product in Respondent’s possession at the time of the August 14, 2023 inspection are adulterated and misbranded and violate Section 331(c) of the Act.

VII.   FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT

The “relevant statute” in this case is actually a combination of statutes and regulations:  The Family Smoking Prevention and Tobacco Control Act, Pub. L. No. 111 31, 123 Stat. 1776 (2009) (TCA), amended the Food, Drug, and Cosmetic Act, 21 U.S.C.A. Chap. 9, (FDCA) and created a new subchapter of that Act that dealt exclusively with tobacco products, 21 U.S.C. §§ 387-387u, and it also modified other parts of the FDCA explicitly to include tobacco products among the regulated products whose misbranding can give rise to civil, and in some cases criminal, liability.  The 2009 amendments to the FDCA contained within the TCA also charged the Secretary of Health and Human Services with, among other things, creating regulations to govern tobacco sales.

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As of August 8, 2016, pursuant to 21 U.S.C. §§ 387a and 387f(d) (Section 906(d) of the Act), FDA revised the definition of tobacco products to incorporate additional products, subject to regulation under the Act.  These products include, but are not limited to, electronic nicotine delivery systems (including e-cigarettes), e-liquids, and pipe tobacco.  See Final Rule, Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, 8 Fed. Reg. 28,974 (May 10, 2016), available at https://federalregister.gov/a/2016-10685 (hereafter “Deeming Regulation”).

The TCA prohibits the sale of any “new tobacco product” without authorization from the FDA.  21 U.S.C. § 387(j)(a); 21 U.S.C. § 387a(b) (delegating the FDA the authority to determine what constitutes new tobacco products).  A new tobacco product is any tobacco product that was not commercially marketed in the United States as of February 15, 2007.  21 U.S.C. § 387j(a)(1).  The Secretary’s regulations on tobacco products appear in Part 1140 of Title 21, Code of Federal Regulations (CFR).

The TCA requires new tobacco products to have a premarket authorization in effect.  21 U.S.C. § 387j(a)(2).  To obtain premarket authorization, manufacturers of new tobacco products are required to submit a premarket tobacco application (PMTA) to the FDA for approval to sell their products.  21 U.S.C. § 387j(b)(1).  Alternatively, the product manufacturer may submit a substantial equivalence report, in response to which the FDA may issue an order finding the product is substantially equivalent to a predicate tobacco product.  21 U.S.C. § 387e(j).  Or, the product manufacturer may submit a report,

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in response to which the Secretary may issue an exemption order.  21 U.S.C. § 387e(j)(3).

The TCA directs FDA to review PMTAs to determine whether “permitting such tobacco product to be marketed would be appropriate for the protection of the public health.”  21 U.S.C. § 387j(c)(2)(A).  Absent an approval from the FDA, the new tobacco products are considered adulterated and misbranded if they lack the required FDA marketing authorization order, substantial equivalence order, or an exemption order.  21 U.S.C. §§ 387b(6) and 387c(6).

Under the FDCA, “[a] tobacco product shall be deemed to be misbranded if, in the case of any tobacco product sold or offered for sale in any State, it is sold or distributed in violation of regulations prescribed under section 387f(d).”  Under 21 U.S.C. § 387c(a)(6), a new tobacco product is misbranded if a “notice or other information respecting it was not provided as required” under the substantial equivalence or substantial equivalence exemption pathway, including a substantial equivalence report or an abbreviated report.  21 U.S.C. § 387c(a)(6).  Section 387 a-1 directed FDA to re-issue, with some modifications, regulations previously passed in 1996.  21 U.S.C. § 387 a-1(a) (2012).

Under the FDCA, a tobacco product is adulterated if it has not obtained the required premarket authorization.  21 U.S.C. § 387b(6)(A).  Thus, when a retailer does not submit a PMTA for its ENDS products, or when a retailer submits a PMTA for its ENDS products and receives a denial order, the products are being adulterated. 21 U.S.C. § 387b(6)(A).  The adulterated and misbranded ENDS products in turn violates the FDCA.

The FDCA prohibits the receipt in interstate commerce of any tobacco product

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that is adulterated or misbranded and the delivery or proffered delivery thereof for pay or otherwise.  21 U.S.C. § 331(c).  The FDA may seek a civil money penalty from “any person who violates a requirement of this chapter which relates to tobacco products.”  21 U.S.C. § 333(f)(9)(A) (2012).  Penalties are set by 21 U.S.C. § 333 note and 21 C.F.R. § 17.2.

VIII.  LIABILITY

When a retailer such as Respondent is found to have “misbranded” a tobacco product in interstate commerce, it can be liable to pay a civil money penalty.  21 U.S.C. §§ 331, 333.

I find and conclude that the evidentiary facts, by a preponderance of the evidence standard, support a finding Respondent violated 21 U.S.C. § 331(c), on August 14, 2023, in that Respondent received an adulterated and misbranded ENDS product in interstate commerce and delivered or proffered delivery thereof for pay or otherwise, as set forth in the Complaint.

IX.    PENALTY

There being liability under the relevant statute, I must now determine the amount of penalty to impose.  Pursuant to 21 U.S.C. § 333(f)(9), Respondent is liable for a civil money penalty not to exceed the amounts listed in FDA’s civil money penalty regulations at 21 C.F.R. § 17.2.  In its Complaint, CTP sought to impose the maximum penalty amount of $20,678 against Respondent for violating the Act.  Complaint ¶ 1.

Since I found that CTP met its burden by a preponderance of the evidence and concluded that Respondent committed violation of the Act, the next step is to determine

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the amount of the civil money penalty.  When making that determination, I am required to consider “the nature, circumstances, extent, and gravity of the violations, and with respect to the violator, ability to pay, effect on ability to continue to do business, any history of prior such violations, the degree of culpability, and such other matters as jus may require.”  21 U.S.C. § 333(f)(5)(B).

1. The Nature, Circumstances, Extent, and Gravity of the Violation

The TCA was enacted for the purpose of authorizing regulation of tobacco products for the “protection of the public health.”  21 U.S.C. § 387f(d).  Respondent was selling a product that did not have premarketing authorization from the FDA, meaning it was not approved for sale or consumption.  Respondent was issued a written warning on June 5, 2023, that the “FDA has determined that your establishment markets new tobacco products lacking premarket authorization in the United States.  All new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully and are subject to enforcement action at FDA’s discretion.”  CTP Ex. 7 at 3.  As part of its exhibits, CTP submitted the June 5, 2023 Warning Letter which it sent to the Respondent.  CTP Ex. 7.  In its Answer, Respondent acknowledged receiving the June 5, 2023 Warning Letter, but asserts that the Warning Letter references a different product than the one referenced in the Complaint.  Answer at 2.

I have reviewed the June 5, 2023 Warning Letter, and it does reflect that the product CTP identified was “Esco Bars Rainbow ENDS product” not the “Esco Bars Fuji Apple Ice ENDS product” subsequently referenced in the Complaint.  I find that it was not unreasonable for Respondent to believe that removing the specific product identified

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in the Warning Letter was sufficient to remedy the violation.  The Warning Letter begins by notifying Respondent “was observed to be in violation of the federal tobacco laws and regulations and states” … “[f]ailure to address this violation may result in FDA initiating regulatory or legal action, including monetary penalties.”  CTP Ex. 7 at 1 (underline in original replaced with bold, italics added for emphasis).  The Warning Letter further stated that “on May 1, 2023, the establishment offered for sale an Esco Bars Rainbow ENDS product” and instructs the Respondent to “take prompt action to address the violation listed above.”  Id. at 1, 3.

The Warning Letter does not clearly indicate if other products being sold by Respondent may also lack the premarket authorization.  See id.  While the Warning Letter generally states that the “violation indicated in [the] letter may not be a complete list at the establishment,” I note that this statement is in the middle paragraphs on page 3 of 5, without underlining or other marking to highlight this statement.  Id. at 3.  Had this indication been more prominently placed or plainly written, I might have given more consideration to CTP’s argument that Respondent’s violations are particularly serious because they occurred despite being previously warned.

However, according to the Respondent’s unrebutted testimony, remedial action was taken after receiving the warning letter, “[a]fter I got that letter, I took that specific vape item off the shelves at my own cost.  Months later I got another letter saying that the store was being charged for selling different vape products. When I found that out, I took all of the similar vape products off my shelves at my own cost.”  R. Ex. 5 – Final ¶¶ 7-9.

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Furthermore, the administrative record also supports Respondent’s contention that it took remedial action in response to the Warning Letter and does not show “unwillingness” to comply with the law.  For instance, the photographs from the August 14, 2023 inspection do not show the specific products identified in the Warning Letter and CTP does not allege those products remained available for sale on August 14, 2023, which supports Respondent’s claim that it removed them upon receipt of the Warning Letter.  CTP Ex. 5 at 4.

Therefore, I also give weight to Respondent’s statement that it “has removed ALL Escobar products from its store as a result of the Complaint.”  Answer at 2.  As such, the evidence provided by the Respondent shows that remedial action was taken after receipt of the inspection results following the May 1, 2023 initial inspection, and also after receipt of the Complaint.

Therefore, I find that after Respondent was given notice of the current violation, Respondent did not continue to sell tobacco products that did not have FDA’s premarket authorization.  Further, despite the serious nature of the violations, I find the Respondent’s attempt to comply with law, while insufficient to relieve it of liability, is a mitigating factor that supports a reduction in the proposed CMP amount.

2. Respondent’s Ability to Pay and Effect on Ability to do Business.

In evaluating this factor, I note that Respondent’s principal argument against the appropriateness of the CMP amount is its inability to pay.  In its Complaint, CTP seeks to impose a CMP amount of $20,678 against Respondent.  Complaint ¶ 1.  In its Answer, Respondent contends that the CMP sought by CTP is too high because it was warned of a

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different product in the Warning Letter, and that Respondent “cannot afford” to pay the CMP.  Answer at 2.  In addition, Respondent summarizes its arguments against the payment of the $20,678 CMP as follows:

The maximum civil money penalty is not appropriate based on the totality of the facts and circumstances.  First, Respondent was dealt the maximum penalty on its first offense.  Second, Respondent believed that it was in compliance when it removed the tobacco product identified in the Warning Letter.  Respondent and its ownership understood the Warning Letter to have identified all prohibited tobacco products on its shelves.  Third, Respondent relied upon its wholesale distributor to provide it with products that were in compliance with laws and regulations.  Finally, Respondent simply cannot survive a civil money penalty of this size based on its finances, including income, cash reserves, and assets.

CRD Dkt. Entry No. 25 at 4.

In support, Respondent has submitted its 2022 and 2023 Financial Statements that comparatively reflect a significant reduction in its business income, showing that its net income was $3,789.45 in 2023 compared to a net income of $28,106.83 in 2022.  Ex. 1B - Final at 4; Ex. 1A - Final at 4; see also Ex. 5 - Final ¶ 12.  CTP did not respond to or dispute Respondent’s arguments with regards to its inability to pay the $20,278 CMP, nor did CTP object to Respondent’s submission of the financial statements.  Respondent also submitted a declaration by the owner, stating his current financial unattainable position, if he has to pay the proposed $20,678 CMP.  Ex. 5 – Final.

Based on this evidence and in light of CTP’s failure to directly address or respond

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to Respondent’s financial evidence, I find Respondent’s contentions regarding its inability to pay the $20,678 CMP sought by CTP due to its financial condition to be sincere and credible, and the evidence persuasive on this issue.

3. History of Prior Violations

There is no indication in the record of any prior violations of Section 331(c) resulting in a CMP.   However, Respondent did receive a Warning Letter dated June 5, 2023, advising that it was in violation of federal law for selling new tobacco products without marketing authorization.  CTP Ex. 7.  It is CTP’s position that Respondent received a Warning Letter that it had previously violated the law and that Respondent continued to receive in interstate commerce and offer for sale a new tobacco product that lacked the required premarket authorization, which shows an unwillingness or inability to comply with the law.  CRD Dkt. Entry No. 10 at 10.  CTP therefore proffers Respondent’s repeated violation supports a penalty of $20,678.

I disagree with CTP’s contentions that Respondent’s repeated violation in this case was based on an unwillingness or inability to comply with the law.  As explained previously, Respondent acted upon receipt of CTP’s Warning Letter to remedy the violation identified in the Warning Letter.  Therefore, I find that the history of violations in this case is not as significant as CTP contends, and accordingly should not favor towards a larger CMP amount.

4. Degree of Culpability

As noted above, Respondent received written notice that it was in violation of federal law by selling a “new tobacco product” that did not have a marketing

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authorization order.  Respondent claims, and the evidence support, that the Warning Letter Respondent received addressed a different product than the one identified in the Complaint.  Respondent removed the product identified in the Warning Letter, and also subsequently removed from its store all vape products.

5. Penalty

Based on my finding that Respondent committed the violation alleged in the Complaint, I hold Respondent culpable for offering for sale a new tobacco product that was adulterated and misbranded, in violation of the Act.  I acknowledge that the Act places a heavy burden on retailers who choose to sell tobacco products because of their highly dangerous and addictive nature.  See 21 U.S.C. § 387 note.  However, as explained above, Respondent has demonstrated its attempt to remedy the violation identified in the Warning Letter and the Complaint.  Although Respondent’s remedial actions are insufficient to relieve it of liability as a retailer of tobacco products, Respondent’s actions do demonstrate that Respondent was serious about correcting its violations of the law.

Further, the Act gives me discretion to consider any other evidence or arguments to mitigate the amount of the CMP.  21 U.S.C. § 333(f)(5)(B).  As previously discussed, CTP does not address or dispute financial statements which reflect that Respondent’s business has experienced financial loss over the past two years.  As such, I find the proposed penalty amount of $20,678 will place a significant financial strain on Respondent.  Having found Respondent violated the law, the CMP should be meaningful to ensure future compliance with the Act and tobacco regulations.

In determining an appropriate penalty for the violation in this case, I have

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considered the purpose of the Tobacco Control Act, which was stated to be the protection of public health.  21 U.S.C. § 387f(d).  The CMP should not then be so punitive as to damage any future viability, but instead be sufficient to penalize Respondent for violating the Act and to deter it from doing so again in the future.

Based on the foregoing, I conclude a reduced penalty amount of $10,500 to be appropriate under 21 U.S.C. §§ 333(f)(5)(B) and 333(f)(9).

X.      CONCLUSION

Respondent received in interstate commerce an ENDS product that lacks the premarketing authorization required under the Federal Food, Drug, and Cosmetic Act and offering such product for sale, as set forth in the Complaint.  Respondent is liable for a reduced civil money penalty of $10,500.  See 21 C.F.R. § 17.2.

WHEREFORE, evidence having read and considered it be and is hereby ORDERED as follows:

1. I find Respondent has been served with process herein and is subject to this forum.
2. I find and conclude that the evidentiary facts, by a preponderance of the evidence standard, support a finding Respondent violated 21 U.S.C. § 331(c) on August 14, 2023.
3. I assess a reduced civil monetary penalty in the amount of $10,500.

Endnotes

¹  See 5 C.F.R. § 930.204.

²  See also Butz v. Economou, 438 U.S. 478 at 513 (1978); Marshall v. Jerrico, Inc., 446 U.S. 238 (1980); Federal Maritime Com’n v. South Carolina State Ports Authority, 535 U.S. 743, 744 (2002).